Croma Electrosurgical Generator
4 catalogue numbers from PRD-EMR-050, listed by Creo Medical Ltd, United Kingdom, under Unit, Electrosurgical, Endoscopic (With Or Without Accessories). 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
4catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (3), Jiangsu (2), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| Anrei Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 12 |
| Hebei Lufen Tech Co., Limited | Xingtai | Hebei | Contract manufacturer | 12 |
| Zhejiang Soudon Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 9 |
Record
| Listed by | Creo Medical Ltd, United Kingdom |
|---|---|
| FDA product code | KNS |
| Device type | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4300 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K242983 |
| Record published | 2025-02-10 |
| Record revised | 2026-04-20 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 69 to 106 KiloPascal; Storage environment atmospheric pressure 69 to 106 KiloPascal; Storage environment humidity 10 to 90 % RH; Storage environment temperature 0 to 30 °C; Handling environment humidity 10 to 90 % RH; Handling environment temperature -20 to 50 °C |
| Packaging | Carton |
| Distribution end date | 2026-04-17 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PRD-EMR-050 | In distribution | |
| 7-EMR-050 V6.001 | In distribution | |
| 7-EMR-050 V4.0 | Withdrawn | |
| 7-EMR-050 V3.0 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Guenter Bissinger Medizintechnik GmbH | Günter Bissinger Medizintechnik GmbH | 93 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Hangzhou AGS MedTech Co., Ltd. | 73 |
| Sphincterotome short-wire compatible | Micro-Tech (Nanjing) Co., Ltd. | 73 |
| Zksk | Beijing Zksk Technology Co., Ltd. | 72 |
| Single Use Preloaded Sphincterotome V(Distal Wireguided) | Olympus Medical Systems Corp. | 40 |
| Single Use Preloaded Sphincterotome V | Olympus Medical Systems Corp. | 40 |
| Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | 40 |
| Single Use 3-Lumen Sphincterotome V | Olympus Medical Systems Corp. | 37 |
| Single Use Electrosurgical Knife | Micro-Tech (Nanjing) Co., Ltd. | 21 |
| Single Use Sphincterotome V(Distal Wireguided) | Olympus Medical Systems Corp. | 20 |
| Cook | Cook Incorporated | 18 |
| Olympus | Olympus Winter & IBE Gmbh | 18 |
Showing 12 of 177. All products under Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242774 | 2025-06-06 |
| K242061 | 2024-08-15 |
| K230328 | 2023-10-31 |
| K192905 | 2020-03-19 |
| K171983 | 2017-08-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.